Dartmouth-Hitchcock Medical Center
Form 483 issued December 17, 2015 · Lebanon, New Hampshire
- Inspection
- Dec 16 – Dec 17, 2015
- Investigators
- Abby E. Pelletier· Sherry K. Markwell· Stephen C. Smith
- Observations
- 3
- Pages
- 3
- FEI number
- 3012030481
In short: On December 17, 2015, FDA issued a Form 483 with 3 observations to Dartmouth-Hitchcock Medical Center in Lebanon, New Hampshire (FEI 3012030481) after an inspection that ran Dec 16 – Dec 17, 2015. The investigators were Abby E. Pelletier, Sherry K. Markwell and Stephen C. Smith. Most observations concern cAPA.
At a glance
3 of 3 observations on this 483 concern capa.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Written MDR procedures have not been developed and…
- 02
The user facility did not submit FDA Form 3500A or electronic equivalent to the known device…
- 03
MDR event files have not…
This inspection in context
Abby E. Pelletier
1 document · 2015
Cites 803.17 (what are the requirements for developing, maintaining, and implementing written mdr procedures that apply to me?) more than any other section. Most of their documents are for sites in New Hampshire.
The firmDartmouth-Hitchcock Medical Center history
The site's inspection history, in date order.
Similar 483sOther sites cited under 803.17
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Dartmouth-Hitchcock Medical Center?
FDA listed 3 observations on this Form 483, mostly about cAPA. The opening words of each observation are shown on this page.
Who inspected Dartmouth-Hitchcock Medical Center?
Abby E. Pelletier, Sherry K. Markwell and Stephen C. Smith are named on this Form 483, for the inspection of Dec 16 – Dec 17, 2015. Each investigator has a profile showing what they cite most.
When was Dartmouth-Hitchcock Medical Center inspected by FDA?
The inspection ran Dec 16 – Dec 17, 2015, and the Form 483 is dated December 17, 2015.
How do I get the full Form 483 for Dartmouth-Hitchcock Medical Center?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.